Class II · Moderate risk
PHENOBARBITAL Sodium Injection
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Phenobarbital Elixir
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Cause type: Unapproved drug
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.
What was recalled
Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16
Affected NDC
69367-0172-16
Compare with the code on your package — it is the most precise check available.
Drug: Phenobarbital
- Recalling firm
- Monarch PCM, LLC
- NDC code
- 69367-172-16
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0878-2022 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Phenobarbital recalls
See all
Class II · Moderate risk
PHENOBARBITAL Sodium Injection
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Phenobarbital Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Phenobarbital Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Phenobarbital Oral Solution
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Other recalls by Monarch PCM, LLC
All 2022 recalls
Class II · Moderate risk
Hydroquinone USP
Finished product specification did not meet USP specifications.
Class III · Low risk
Hydroquinone
Subpotency: one product for active ingredient assay and another one for preservative assay
Class III · Low risk
Sodium Sulfacetamide
Subpotency: one product for active ingredient assay and another one for preservative assay
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